Replace Select™ 37316 (UDI 07332747160963)Recalls & reported problems
Nobel Biocare AB · Replace Select™ Tapered PMC 6.0 6.0x10mm · Class 2 · Implant
Quick summary
This Nobel Biocare Replace Select dental implant is placed in the jawbone to support a replacement tooth. Most reports describe implants that failed to fuse with the bone, and some describe a lack of initial stability. The 156 reports include no deaths and 156 injuries. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 157
- Deaths reported
- 0
- Injuries reported
- 157
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 157 adverse event reports that list this exact device (DI 07332747160963), received between Nov 17, 2021 and Aug 22, 2026 — classified as 157 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (106 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate106
- Loss of Osseointegration31
- Osseointegration Problem10
- Migration4
- Patient Device Interaction Problem4
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Failure of Implant112
- No Clinical Signs, Symptoms or Conditions31
- Unspecified Infection16
- Pain10
- Abscess4
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Sinus Perforation2
Recent adverse event reports
The 25 most recent of 157 reports, in the reporter's own words as published by the FDA.
InjuryAug 22, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50392682 ↗InjuryAug 12, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50229232 ↗InjuryAug 12, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50229229 ↗InjuryAug 12, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50229227 ↗InjuryAug 12, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50229226 ↗InjuryAug 12, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50229194 ↗InjuryAug 12, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50229193 ↗InjuryJul 28, 2026Osseointegration Problem
Primary stability couldn¿t be achieved.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50063243 ↗InjuryJul 28, 2026Osseointegration Problem
Primary stability couldn¿t be achieve.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50063236 ↗InjuryJun 17, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25540539 ↗InjuryJun 17, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25540403 ↗InjuryMay 15, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25193377 ↗InjuryMay 15, 2026Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25193375 ↗InjuryMar 5, 2026Failure to Osseointegrate
InjuryMar 5, 2026Failure to Osseointegrate
InjuryDec 20, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23859872 ↗InjuryDec 20, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23859868 ↗InjuryDec 17, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 17, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 3, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23710452 ↗InjuryDec 3, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23710437 ↗InjuryNov 14, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryNov 14, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryOct 29, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23419824 ↗InjuryOct 29, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILURE TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23419820 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.